NCT01522755

Predictive Factors of a Successful Implant of the CapsureFix MRI Model 5086

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 409 (actual)
• Sponsor: Medtronic Cardiac Rhythm and Heart Failure · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Pacing leads are key elements of a pacing system as their proper functioning is one of the major factors affecting the long term performance of the whole system. Success of a pacing lead implant can be defined considering 3 items: ease of lead implant, lead stability and lead electrical performances. These factors may be related to the physician experience (global implant experience, experience with a given lead), to the implant procedure (lead access, lead position, implant time, scopy time) to the lead (handling and mechanical characteristics) and to the patient (ischemic history). Even though implant success rate is quite high with currently available leads, the weight of the different factors influencing success has never been studied systematically. The objective of the current study is then to define the predictive factors of an implant success with the CapsureFix MRI model 5086. This lead has been selected because it has been available for a short period, so the investigators have a limited experience of it and it has a unique design which makes it conditionally safe in an MRI environment and which may be associated with specific handling characteristics.

Conditions

• Bradyarrhythmia

Interventions

Type	Name	Description
DEVICE	Pacing system implant with the CapsureFix MRI pacing lead model 5086	Pacing system implant with the CapsureFix MRI pacing lead model 5086

Timeline

• Start date: 2011-05-01
• Primary completion: 2013-12-01
• Completion: 2013-12-01
• First posted: 2012-02-01
• Last updated: 2025-07-02
• Results posted: 2020-01-18

Locations

1 site across 1 country: France